Sheath apparatus and methods for delivering a closure device

ABSTRACT

An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

RELATED INFORMATION

This application is a continuation of U.S. application Ser. No.10/081,725 now U.S. Pat. No. 6,749,621, filed on Feb. 21, 2002. Thepriority of the prior application is expressly claimed, and thedisclosure of this application is hereby incorporated by reference inits entirety.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forclosing and/or sealing openings through tissue, and more particularly toapparatus and methods for delivering a closure element for closing apuncture in a blood vessel or other body lumen formed during adiagnostic or therapeutic procedure.

BACKGROUND

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wiremay then be passed through the needle lumen into the patient's bloodvessel accessed by the needle. The needle may be removed, and anintroducer sheath may be advanced over the guide wire into the vessel,e.g., in conjunction with or subsequent to a dilator. A catheter orother device may be advanced through a lumen of the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate introduction ofvarious devices into the vessel, while minimizing trauma to the vesselwall and/or minimizing blood loss during a procedure.

Upon completion of the procedure, the devices and introducer sheath maybe removed, leaving a puncture site in the vessel wall. Externalpressure may be applied to the puncture site until clotting and woundsealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forexample, U.S. Pat. No. 5,676,974, issued to Kensey et al., discloses ableed back lumen intended to facilitate positioning of a biodegradableplug within a puncture site. This device, however, requires that ananchor of the plug be positioned within the vessel, and therefore, mayincrease the risk of over-advancement of the plug itself into thevessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel. The loop may also provide a supportfor facilitating the deployment and deflection of a surgical clipagainst the vessel wall. Such a device, however, may risk engagementbetween the loop and the surgical clip, thereby preventing the loop frombeing withdrawn from the vessel.

Accordingly, apparatus and methods for delivering a device for closing avascular puncture site or other opening through tissue would be useful.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for closingand/or sealing openings through tissue, e.g., into body lumens, and moreparticularly to apparatus and methods for delivering a vascular closureelement for closing a puncture in a blood vessel formed during adiagnostic or therapeutic procedure.

In accordance with one aspect of the present invention, an apparatus isprovided for delivering a closure element or other annular-shaped deviceinto an opening through tissue, e.g., for engaging tissue adjacent theopening to close and/or seal the opening. The apparatus generallyincludes an elongate member including proximal and distal ends defininga longitudinal axis therebetween, and an outer surface extending betweenthe proximal and distal ends. In one embodiment, the elongate member maybe an introducer sheath that includes a lumen for advancing one or moredevices into a body lumen during a procedure.

A carrier assembly may be slidable on the elongate member from theproximal end towards the distal end, the carrier assembly including acarrier member and a pusher member movable distally relative to thecarrier member. A distal end of the pusher member may be disposedproximal to a distal end of the carrier member, e.g., if the pushermember has a substantially shorter length than the carrier member,thereby defining a space distal to the pusher member along an outersurface of the carrier member. An annular-shaped element, e.g., a clipor other closure device, may be received on the carrier member, theannular-shaped element being deployable from the carrier member upondistal movement of the pusher member relative to the carrier member.

Optionally, the carrier member may include one or more ramped portions,each portion defining a ramped distal surface and/or a ramped proximalsurface. The closure element may include a plurality of tines extendingdistally, the tines being disposed proximal to the one or more rampedportions such that the ramped portions may protect the tines duringadvancement of the carrier assembly. In addition, the pusher member mayadvance the closure element over the one or more ramped portions whenthe carrier assembly is advanced to a distal position, e.g., fordirecting the tines radially outwardly to engage surrounding tissue.

A skin overlies at least a portion of the outer surface of the elongatemember and the carrier assembly, the skin being separable from the outersurface of the elongate member as the carrier assembly is advanced fromthe proximal end towards the distal end of the elongate member. In oneembodiment, the skin may include a weakened region, e.g., a thin and/orperforated region, extending axially along the skin. The weakened regionmay be configured to tear preferentially as the carrier assembly isadvanced from the proximal end towards the distal end of the elongatemember. In another embodiment, the skin may include a flap extendingaxially along the outer surface of the elongate member and overlying anadjacent region of the skin. The flap may be bonded to the adjacentregion such that the flap may be separated from the adjacent region asthe carrier assembly is advanced towards the distal end of the elongatemember.

In addition or alternatively, the skin may be bonded to the outersurface of the elongate member by an adhesive. The adhesive may havesufficient adhesive strength such that the skin may be peeled away fromthe outer surface as the carrier assembly is advanced towards the distalend of the elongate member.

The apparatus may also include an actuator assembly including a housingextending from the proximal end of the elongate member, e.g.,connectable by cooperating detents, and one or more elongate actuatorelements that are movable axially relative to the housing. The actuatorelements may be connected to the carrier assembly for coupling movementof the carrier assembly to the one or more actuator elements. Forexample, the carrier assembly and the actuator elements may includecooperating detents for coupling distal movement of the carrier assemblyto the one or more actuator elements as the control member is directeddistally. The cooperating detents may release the carrier member uponattaining a distal position, thereby permitting further distal movementof the pusher member to deploy the closure element from the carriermember.

During use, the distal end of the elongate member may be inserted intoan opening through tissue, e.g., into a puncture communicating with anartery or other blood vessel. If the elongate member is an introducersheath, one or more instruments may be inserted through the sheath,e.g., into a blood vessel accessed via the opening. A diagnostic and/ortherapeutic procedure may be performed within a patient's body, e.g.,via the blood vessel accessed via the opening. Upon completion of theprocedure, any instruments may be removed from the sheath, the handleassembly may be connected to the proximal end of the elongate member,and/or an actuator may be coupled to the carrier assembly. Optionally,the distal end of the elongate member may be positioned relative to theblood vessel, e.g., using a bleedback indicator or a tactile indicator,such as an expandable obturator.

To deploy the closure element, the carrier assembly may be advancedtowards the distal end of the elongate member. The carrier assembly maycause the skin to separate from the outer surface of the elongate memberas the carrier assembly is advanced towards the distal end. If the skinincludes a weakened region extending towards the distal end of theelongate member, the weakened region may tear preferentially as thecarrier assembly is advanced towards the distal end of the elongatemember. If the skin includes a flap extending axially along the outersurface of the elongate member and overlying an adjacent region of theskin, the flap may be released from the adjacent region as the carrierassembly is advanced towards the distal end of the elongate member,thereby allowing the skin to separate from the outer surface. Inaddition or alternatively, if the skin is bonded to the outer surface ofthe elongate member by an adhesive, the adhesive may have sufficientadhesive strength to release as the carrier assembly directs the skinoutwardly such that the skin is separated from the outer surface as thecarrier assembly is advanced towards the distal end.

As the carrier assembly is advanced, the carrier assembly may passbetween the skin and the outer surface of the elongate member. Thus, ifthe opening through tissue extends through one or more layers of fasciaor other tissue structures, the skin may facilitate advancing thecarrier assembly through the layers and/or minimize the risk of thecarrier assembly or the closure element catching on tissue as it isadvanced towards the distal end of the elongate member.

The closure element may be deployed from the carrier assembly within theopening, e.g., by ejecting the closure element from the carrier assemblyand/or by withdrawing the elongate member from the opening. With theelongate member withdrawn, the closure element may substantially closeor seal the opening, e.g., to prevent blood flow therethrough, therebyallowing the opening to heal.

In accordance with another aspect of the present invention, an apparatusis provided for delivering a closure device that includes an elongatemember, e.g., an introducer sheath, including proximal and distal endsdefining a longitudinal axis therebetween, and an outer surfaceextending between the proximal and distal ends. A hub may be provided onthe proximal end of the elongate member, the hub including one or morealignment tabs or spacers disposed about the periphery of the hub and/orspaced away from the outer surface of the elongate member.

A closure element, e.g., a clip, may be provided that includes agenerally annular-shaped body including proximal and distal ends and aplurality of tissue engaging portions extending from the distal end. Theproximal end of the closure element may be held away from the outersurface of the elongate member by the one or more spacers.

An actuator or handle assembly is provided that includes an actuatormember slidable between the hub and the outer surface of the elongatemember. The actuator member includes one or more elements for couplingwith the closure element, whereby distal movement of the actuator memberadvances the closure element towards the distal end of the elongatemember. In one embodiment, the hub may include an annular hub defining apassage between the annular hub and the outer surface of the elongatemember, e.g., attached to the elongate member by one or more radialspokes. The actuator member may include a tubular member, e.g., defininga “C” shaped cross-section for inserting the tubular member through thepassage around the one or more radial spokes.

In a preferred embodiment, the tubular member may include one or moreprotrusions or tabs, e.g., extending radially outwardly from the distalend of the tubular member. The closure element may include a pluralityof pockets for receiving respective tabs on the tubular member therein,thereby coupling the closure element to the tubular member using thetabs. For example, the closure element may include a plurality ofalternating diagonal elements extending between the proximal and distalends of the closure element. The distal end of the closure element mayinclude curved elements connecting adjacent diagonal elements, thecurved elements defining the pockets.

Optionally, a skin may overlie at least a portion of the outer surfaceof the elongate member between the carrier assembly and the distal endof the elongate member, and may at least partially overlie the closureelement. The skin may be separable from the outer surface as the closureelement is advanced towards the distal end of the elongate member,similar to the previous embodiment.

During use, the distal end of the elongate member may be inserted intoan opening through tissue, e.g., into a puncture communicating with ablood vessel, and a procedure may be performed, similar to the previousembodiment. Upon completing the procedure, a distal end of the actuatormember may be inserted between the hub and the outer surface of theelongate member. Thus, the actuator member may pass under the spacers,and consequently, under the proximal end of the closure element, untilthe distal end of the actuator member is coupled with the closureelement, e.g., received in pockets adjacent the distal end of theclosure element. The actuator member may be advanced distally, therebyadvancing the closure element towards the distal end of the elongatemember. Tissue adjacent the distal end of the elongate member may beengaged with tissue engaging elements on the closure element, and theelongate member may be withdrawn from the opening, leaving the closureelement to close and/or seal the opening. Alternatively, the closureelement may be carried by the distal end of the actuator member, ratherthan being disposed initially adjacent the hub. In this alternative, theclosure element may be introduced between the hub and the elongatemember when the actuator member is connected to the hub, and advancedalong the elongate member as the actuator member is advanced.

Other objects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded side view of a first preferred embodiment of anapparatus for delivering a closure element, including an introducersheath, an actuator assembly, and an obturator, in accordance with thepresent invention.

FIG. 2 is a cross-sectional side view of the apparatus of FIG. 1.

FIGS. 3A and 3B are cross-sectional views of alternative embodiments ofthe introducer sheath of FIG. 1.

FIG. 4 is a side view of the apparatus of FIG. 1, with the actuatorassembly connected to the sheath, and an obturator inserted through theactuator assembly and sheath.

FIGS. 5A and 5B are perspective views of the distal end of the obturatorof FIG. 4, showing positioning elements on the obturator in collapsedand expanded configurations, respectively.

FIGS. 6A-6G are cross-sectional views of a blood vessel, showing amethod for delivering a clip into with a wall of the vessel.

FIG. 7 is a perspective view of a second preferred embodiment of anapparatus for delivering a closure element, including an introducersheath, and an actuator assembly, in accordance with the presentinvention.

FIG. 8 is a perspective detail of the apparatus of FIG. 7 with theactuator assembly attached to the introducer sheath.

FIGS. 9A-9C are cross-sectional details of the apparatus of FIGS. 7 and8.

FIG. 10 is a cross-sectional view of a blood vessel, showing a closureelement being delivered by the apparatus of FIG. 7.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, FIGS. 1, 2, and 4 show a first preferredembodiment of an apparatus 10 for delivering a closure element, such asa clip 5, into an opening through tissue for closing and/or sealing theopening (not shown). Generally, the apparatus 10 includes an introducersheath 12, a housing or carrier assembly 14 slidably disposed on thesheath 12, and a skin 44 overlying the sheath 12 and/or carrier assembly14. The apparatus 10 may also include an actuator or handle assembly 16that is connectable to the sheath 12. Optionally, as shown in FIG. 4,the apparatus 10 may also include a locator member or obturator 18 thatmay be insertable through the actuator assembly 16 and/or sheath 12 forassisting positioning of the apparatus, as described further below.

The sheath 12 is generally a substantially flexible or semi-rigidtubular member including a lumen 20 extending along a longitudinal axis28 between its proximal and distal ends 22, 24. The distal end 24 has asize and shape to facilitate insertion into an opening through tissue(not shown), e.g., having a tapered tip 26 for facilitatingsubstantially atraumatic introduction through a passage and/or at leastpartially into a blood vessel or other body lumen accessed via thepassage. The lumen 20 has a size for accommodating insertion of one ormore devices therethrough, such as a catheter, guidewire, and the like(not shown). The sheath 12 may also include a seal (not shown), such asa hemostatic valve, within the lumen 20, e.g., at or near the proximalend 22, that may provide a fluid-tight seal, yet accommodate insertingone or more devices, such as the obturator 18, into the lumen 20 withoutfluid passing proximally from the sheath 12.

An annular hub 30 may be provided on the proximal end 22 of the sheath12, e.g., attached by one or more radial spokes, such as the spoke 31shown in FIG. 2. Preferably, the hub 30 and the sheath 12 define a “C”shaped passage 38 (or multiple passages if multiple spokes are provided)therebetween that extends substantially parallel to the longitudinalaxis 28. In addition, the hub 30 may include one or more connectors onits proximal end 32, such as recesses or pockets 34, for cooperatingwith mating connectors 80 on the actuator assembly 16, as describedfurther below. Alternatively, the actuator assembly 16 may beconnectable directly to the proximal end 22 of the sheath 12 (notshown), may be provided as an integral component of the sheath 12 (notshown), or may otherwise extend from the proximal end 22 of the sheath12, e.g., such that the hub 30 may be eliminated.

Optionally, the hub 30 may include a side port (not shown) thatcommunicates with the lumen 20, for example, to allow infusion of fluidsinto the lumen 20 through the sheath 12. Alternatively, or in addition,the side port may be used to provide a “bleed back” indicator, such asthat disclosed in co-pending application Ser. No. 09/680,837, filed Oct.6, 2000, which is assigned to the assignee of the present invention. Thedisclosure of this application and any references cited therein areexpressly incorporated herein by reference.

In a further alternative, the spokes 31 may be eliminated from the hub30, and the hub 30 may be secured to the sheath 12 by an annular seal orother frictional member (not shown). When the actuator assembly 16 isattached to the sheath 12, as described further below, the hub 30 may atleast partially break away or may be secured to the actuator assembly16. The actuator assembly 16 and/or the obturator 18 may frictionally ormechanically become secured to the sheath 12 to prevent the apparatus 10from separating during use.

The carrier assembly 14 is slidably disposed on an outer surface 13 ofthe sheath 12 and is configured for releasably holding the clip 5. Thecarrier assembly 14 is slidable from a proximal position, e.g., adjacentthe hub 30, and preferably at least partially disposed within thepassage 38, towards the distal end 24 of the sheath 12.

With particular reference to FIG. 2, the carrier assembly 14 may includean inner or carrier member 40 and an outer or pusher member 42 that arenested together and coaxially disposed around the sheath 12. The carriermember 40 is an annular-shaped body including proximal and distal ends46, 48, and a ramped region 50 adjacent the distal end 48. The rampedregion 50 may include a ramped proximal surface 50 a, e.g., forfacilitating deployment of the clip over the ramped region 50, and/or aramped distal surface 50 b, e.g., for facilitating advancement of thecarrier assembly 14, as described further below. The distal end 48 ofthe carrier member 40 may be tapered, and/or, alternatively, the carriermember 40 may include a plurality of ramped regions (not shown) adjacentthe distal end 48, rather than a single annular ramped region, e.g.,spaced evenly about a perimeter or other periphery of the carrier member40.

The carrier member 40 may include a connector (not shown) on theproximal end 46 for coupling the carrier member 40 to the actuatorassembly 16. Alternatively, the carrier member 40 may be coupled to thehub 30 and/or to the proximal end 22 of the sheath 12 by a tether orother element (not shown) for limiting distal movement of the carriermember 40, as described further below.

The pusher member 42 may also be an annular body, including proximal anddistal ends 56, 58 and may include a connector (not shown) on itsproximal end 56 for coupling the pusher member 42 to the actuatorassembly 16. The distal end 58 may be substantially blunt to engage theclip 5, e.g., to advance or deploy the clip 5 from the carrier assembly14, as described further below. The pusher member 42 is configured toslidably fit around the carrier member 40, but has a substantiallyshorter length than the carrier member 40, such that the carrier andpusher members 40, 42 define a space 15 distal to the distal end 58 ofthe pusher member 42 and along an outer surface of the carrier member 40for receiving the clip 5.

The carrier assembly 14 may be used to deploy a clip 5 or other closureelement from the space 15 defined by the carrier assembly 14. In apreferred embodiment, the clip 5 is a generally annular-shaped body,including one or more tines 7 for engaging the tissue around an opening,e.g., adjacent to a wall of a blood vessel (not shown). Preferably, theclip 5 is configured for drawing the tissue around a puncture in thewall of a blood vessel substantially closed and/or sealed, e.g., forenhancing hemostasis within the puncture. Exemplary embodiments of aclosure element for use with an apparatus in accordance with the presentinvention are disclosed in U.S. Pat. No. 6,197,042, and in co-pendingapplication Ser. Nos. 09/546,998 and 09/610,238, the disclosures ofwhich are expressly incorporated herein by reference.

The carrier assembly 14 may be actuated from the proximal end 22 of thesheath 12, preferably by the actuator assembly 16, as explained furtherbelow. The carrier assembly 14 may be substantially permanently butslidably disposed on the sheath 12. For example, the carrier assembly 14may be initially stored at least partially within the passage 38 underthe hub 30. Alternatively, the carrier assembly 14 may be providedseparate from the sheath 12 (not shown), e.g., with the clip 5pre-loaded therein, but may be slidably attached to the sheath 12 beforedeploying the clip 5.

The skin 44 overlies at least a portion of the outer surface 13 of thesheath 12 and the carrier assembly 14. Preferably, the skin 44 extendsfrom the carrier assembly 14 towards the distal end 24 of the sheath 12,e.g., having a proximal end 66 that at least partially covers the clipand a distal end 68 proximate the distal end 24 of the sheath 12. Theskin 44 may be substantially secured over the sheath 12, therebysubstantially securing the skin 44 from moving axially relative to thesheath 12.

The skin 44 may be separable from the outer surface 13 of the sheath 12as the carrier assembly 14 is advanced from its proximal positiontowards the distal end 24 of the sheath 12. For example, the distal end68 of the skin 44 may terminate adjacent the distal position to whichthe carrier assembly 14 may be advanced such that the clip 5 may bedisposed beyond the distal end 68 of the skin 44 in the distal position.

The skin 44 may be substantially inelastic, e.g., such that the skin 44may tear when expanded, or alternatively may be elastic. In addition oralternatively, the skin 44 may include an outer surface 70 that issubstantially slippery to facilitate advancing the sheath 12 throughlayers of tissue (not shown), as described further below. The skin 44may be formed from a variety of materials, e.g., having sufficientflexibility to allow the carrier assembly 14 to be advanced between theskin 44 and the outer surface 13 of the sheath 12 and/or sufficientrigidity to allow the skin 44 to separate or peel away from the outersurface 13 in a predictable and desired manner. Exemplary materials fromwhich the skin 44 may be formed include polytetrafluoroethylene (PTFE),polyethylene terephthalate (PET), polyester, latex, silicone,polyamides, polyurethanes, and/or blends and copolymers thereof. Theskin 44 may have a thickness, for example, between about 0.002-0.005inch. Optionally, the skin 44 may include fibers (not shown) embeddedtherein or on a surface thereof that may reinforce the skin 44 in adesired manner.

The skin 44 may be bonded to the outer surface 13 of the sheath 12,e.g., using an adhesive, such as an epoxy or urethane. Preferably, theadhesive has sufficient adhesive strength such that the skin 44 may notslide along the outer surface 13 of the sheath 12, yet may be peeledaway from the outer surface 13, e.g., as the carrier assembly 14 isadvanced towards the distal end 24 of the sheath 12. Alternatively, theskin 44 may be thermally bonded to the outer surface 13, e.g., byheating the skin 44 and/or sheath 12 to at least partially melt or fusethe skin 44 to the outer surface 13.

Alternatively, the skin 44 may be a tube that is securely receivedaround the outer surface 13. For example, the skin 44 may be a length ofshrink tube, having an initial diameter that is substantially largerthan the sheath 12. The shrink tube may be disposed around the sheath12, heated, and, consequently, shrunk to wrap around or otherwise engagethe outer surface 13 of the sheath 12, either with or without adhesiveprovided between the skin 44 and the outer surface 13.

Optionally, the skin 44 may include a weakened region 72 extendingbetween the proximal and distal ends 66, 68 of the skin 44, as shown inFIG. 1. The weakened region 72 may be configured to tear or splitpreferentially as the carrier assembly 14 is advanced towards the distalend 24 of the sheath 12. For example, the weakened region 72 may includea plurality of perforations spaced apart along the skin 44, therebydefining a seam extending between the proximal and distal ends 66, 68 ofthe skin 44. Alternatively, the weakened region 72 may include arelatively thin-walled seam or region (not shown) of the skin 44 inaddition to or instead of the perforated seam.

In a further alternative, fibers (not shown) embedded in the skin 44 maybias the skin 44 to tear preferentially in a desired manner. Forexample, one or more fibers (not shown) may be may be bonded to the skin44 that extend between the proximal and distal ends 66, 68 of the skin44, thereby defining a seam adjacent or between the fibers that may tearpreferentially. Alternatively, a plastic or other soft material may bebonded over a braided core (not shown) instead of or in addition toindividual fibers, e.g., to create regions of the skin 44 that areresistant to tearing.

Although the weakened region 72 is shown extending substantiallyparallel to the longitudinal axis 28, the weakened region 72 may extendhelically (not shown) or otherwise between the proximal and distal ends66, 68. The term “axially” as used herein is intended to include anyarrangement that may extend generally towards the proximal and/or distalends 22, 24 of the sheath 12. When the carrier assembly 14 is advancedunder the skin 44, the weakened region 72 may tear such that the skin 44separates or peels away from the outer surface 13, as described furtherbelow.

Turning to FIG. 3A, in an alternative embodiment, the skin 44 may be atubular sleeve 44′ that has a relaxed diameter or other periphery thatis substantially larger than a diameter or other periphery of the sheath12. The sleeve 44′ may be wrapped around the outer surface 13 of thesheath 12 until a portion of the sleeve 44′ is folded over itself todefine a flap 45.′ The flap 45′ may then be laid over an adjacent region47′ of the sleeve 44′, whereupon the flap 45′ may be bonded or otherwisefastened in order to secure the sleeve 44′ to the sheath 12. Thus, asthe carrier assembly 14 (not shown in FIG. 3A) is advanced along thesheath 12, the adhesive may fail, and the flap 45′ may separate from theadjacent region 47′ of the sleeve 44′ as the carrier assembly 14 isadvanced towards the distal end 24 of the sheath 12.

Turning to FIG. 3B, in another alternative embodiment, the skin 44 maybe a tubular sleeve 44″ that is slitted generally axially such that thesleeve 44″ defines first and second portions 45″, 47″ including edges.When the edges of the first and second portions 45″, 47″ abut oneanother, the sleeve 44″ defines a diameter or other periphery that issubstantially larger than a diameter or other periphery of the sheath12. The sleeve 44″ may be wrapped around the outer surface 13 of thesheath 12 until the first portion 45″ overlies the second portion 47.″The first or outer portion 45″ may then be bonded or otherwise fastenedto the second or inner portion 47″ in order to secure the sleeve 44″ tothe sheath 12. Thus, as the carrier assembly 14 (not shown in FIG. 3B)is advanced along the sheath 12, the adhesive may fail, and the outerportion 45″ may separate from the adjacent region 47″ as the carrierassembly 14 is advanced towards the distal end 24 of the sheath 12.

The sleeve 44″ may have a substantially uniform thickness about itscircumference. Alternatively, the sleeve 44″ may have a variablethickness about the circumference. For example, the sleeve 44″ may havea relatively thin thickness in the first and second portions 45,″ 47,″which may provide a more uniform overall cross-section for the skin 44,as shown in FIG. 3B.

Returning to FIG. 1, the actuator assembly 16 generally includes ahandle body 74 and a plurality of telescoping actuator members 76, 78.The handle body 74 includes one or more connectors 80 for connecting theactuator assembly 16 to the sheath 12. For example, the handle body 74may include a plurality of tabs 80 for engaging mating pockets 34 in thehub 30 or one or more pockets (not shown) for receiving respective tabs(not shown) on the hub 30 of the sheath 12. Thus, the actuator assembly16 may be substantially permanently attached or removably attached tothe sheath 12 by cooperating connectors 34, 80.

In the preferred embodiment shown, the telescoping actuator members 76,78 include an inner tubular member 76 and an outer tubular member 78.The tubular members 76, 78 may be substantially rigid members havinglongitudinal slots therein (not shown), thereby defining generally “C”shaped cross-sections over at least a substantial portion of theirlengths. Preferably, the longitudinal slots have a width greater than awidth of the spoke(s) 31 securing the hub 30 to the sheath 12, therebyallowing the tubular members 76, 78 to slide distally beyond the hub 30,as described further below. The longitudinal slots may extendpredetermined distances from ends of the respective tubular members 76,78, e.g., to limit movement of the tubular members 76, 78 in a desiredmanner, or may extend the entire length of one or both tubular members76, 78. Alternatively, the longitudinal slots may be eliminated from theactuator members, such that the actuator members are enclosed walltubes, if the spokes are eliminated from the hub 30 (not shown).

The distal ends 82, 84 of the tubular members 76, 78 may include detents(not shown) for engaging respective detents on the carrier assembly 14.For example, the detents may be pockets for receiving respective tabs(also not shown) on the carrier and pusher members 40, 42. Thus,movement of the carrier and/or pusher members 40, 42 may be coupled tothe inner and outer tubular members 76, 78, respectively. Alternatively,the distal ends 82, 84 of the tubular members 76, 78 may simply abut thecarrier and pusher members 40, 42 for pushing the carrier and pushermembers 40, 42, thereby coupling distal movement of the carrier andpusher members 40, 42 to the tubular members 76, 78.

In an alternative embodiment, the tubular members 76, 78 may be replacedwith one or more elongate rods, bands, or other actuator elements (notshown) that may extend from the handle body 74 and may engage, abut, orotherwise be coupled to the carrier assembly 14. Preferably, theactuator elements are substantially rigid such that they do not bucklewhen directed distally against the carrier assembly 14. In addition, theactuator elements may be substantially flat such that they slide alongthe outer surface 13 of the sheath 12, thereby facilitating insertionbetween the hub 30 and the sheath 12 and/or minimizing a cross-sectionalprofile.

The actuator assembly 16 also includes a control member, such as a shaft86, that is coupled to the inner and/or outer tubular members 76, 78.Preferably, the shaft 86 is connected only to the outer tubular member78, while the inner tubular member 76 is releasably coupled to the outertubular member 78, as explained further below. Thus, axial movement ofone or both of the tubular members 76, 78 may be attained by applying anaxial force to the shaft 86.

Optionally, the actuator assembly 16 may also include other components.For example, a lateral port 88 may include an inner passage 89 thatcommunicates with an interior region or lumen (not shown) of thetelescoped tubular members 76, 78. Preferably, the lateral port 88extends through the slots in the tubular members 76, 78, althoughalternatively, separate slots (not shown) may be provided for thelateral port 88. The lateral port 88 may include one or more detents(not shown) for securing the obturator 18 or other device within thelateral port 88, as described below. In addition, the actuator assembly16 may include a trigger (not shown) for releasing the obturator 18, asdescribed further below.

Turning to FIGS. 4, 5A, and 5B, the obturator 18 includes a flexible orsemi-rigid tubular body or other elongate rail 172 having proximal anddistal ends 174, 176. An actuator rod, wire, or other elongate member178 is slidably disposed with respect to the rail 172, e.g., within alumen of the rail 172. Preferably, the obturator 18 includes anobturator housing 180 on the proximal end 174. The obturator housing 180and/or the proximal end 174 of the rail 172 may include one or moredetents (not shown) for engaging complementary-shaped detents (also notshown) on the lateral port 88 of the actuator assembly 16. Thus, theobturator 18 may be substantially secured axially with respect to thelateral port 88.

With particular reference to FIGS. 5A and 5B, a distal portion 182 ofthe obturator 18 may include a substantially rounded, soft, and/orflexible distal tip 184, possibly including a pigtail (not shown) thatmay facilitate atraumatic advancement of the distal portion 182 into ablood vessel or other body lumen (not shown). The obturator 18preferably has a length relative to the sheath 12 such that the distalportion 182 may extend beyond the distal end 24 of the sheath 12 whenthe obturator 18 is fully received in the actuator assembly 16 andsheath 12, as shown in FIG. 4.

One or more, and preferably a plurality of, positioning elements 186 areprovided on the distal portion 182 that may be selectively expandedbetween a substantially axial collapsed configuration (shown in FIG. 5A)and a substantially transverse expanded configuration (shown in FIG.5B). Preferably, the positioning elements 186 are substantially flexiblesplines configured for expanding substantially transversely with respectto the longitudinal axis 28. In one embodiment, shown in FIGS. 5A and5B, the obturator 18 includes a pair of splines 186 disposed generallyopposite one another about the distal portion 182. Alternatively, theobturator 18 may include four or any other number of splines (not shown)that are substantially equally spaced about the distal portion 182.Additional information on positioning elements that may be used aredisclosed in co-pending application Ser. No. 09/732,835, the disclosureof which is expressly incorporated herein by reference.

Optionally, the splines 186 may include radiopaque markers (not shown)or may be at least partially formed from radiopaque material tofacilitate observation of the splines 186 using fluoroscopy or otherimaging systems. Alternatively, or in addition, the carrier assembly 14may include one or more radiopaque markers, e.g., at its distal end (notshown) and/or the clip 5 may include radiopaque marker(s) or may be madefrom radiopaque material. This may facilitate monitoring the location ofthe clip 5 relative to the splines 186, as described further below.

Turning to FIGS. 6A-6G, the apparatus 10 may be used to provide accessinto a blood vessel or other body lumen 90. Preferably, the apparatus 10is used to deliver a closure device, such as the clip 5, to close and/orseal an incision, puncture, or other opening, such as a passage 92 thatextends from a patient's skin 94 through intervening tissue 96, and awall 98 of the vessel 90. Alternatively, the apparatus 10 may be used todeliver other annular shaped devices (not shown) that may be carried bythe carrier assembly 14.

As shown in FIG. 6A, the sheath 12, without the actuator assembly 16attached and without the obturator 18 therein (both not shown), may beinserted or otherwise positioned within the blood vessel 90, i.e.,through the passage 92. The sheath 12 is preferably provided with thecarrier assembly 14 in its proximal position, e.g., adjacent to orwithin the hub 30. The skin 44 may facilitate advancing the sheath 12through the passage 92, e.g., by providing a slippery outer coating onthe skin 44, e.g., of PTFE. In particular, the skin 44 may facilitateadvancing the sheath 12 through one or more intervening layers oftissue, such as layers of fascia 97, which may otherwise catch on thesheath 12.

The sheath 12 may be advanced over a guide wire or other rail (notshown) previously positioned through the passage 92 into the bloodvessel 90 using conventional procedures. Preferably, the blood vessel 90is a peripheral vessel, such as a femoral or carotid artery, althoughother body lumens may be accessed using the sheath 12, as will beappreciated by those skilled in the art. The passage 92, andconsequently the sheath 12, may be oriented with respect to the vessel90, thereby facilitating introducing devices through the lumen 20 of thesheath 12 into the vessel 90 with minimal risk of damage to the vessel90. One or more devices, such as a guide wire, catheter, and the like(not shown), may be inserted through the sheath 12 and advanced to adesired location within the patient's body. For example, the devices maybe used to perform a therapeutic or diagnostic procedure, such asangioplasty, atherectomy, stent implantation, and the like, within thepatient's vasculature.

After completing the procedure, any device(s) may be removed from thesheath 12, and the actuator assembly 16 may be attached to the hub 30 ofthe sheath 12, as shown in FIG. 6B. The tabs 80 on the actuator assembly16 may be inserted into the pockets 34 on the hub 30 of the sheath 12(not shown in FIG. 6B), which may align the tubular members 76, 78 suchthat the distal ends 82, 84 may be inserted freely into the passage 38.If the carrier assembly 14 includes detents (not shown) for beingengaged with the distal ends 82, 84 of the tubular member 76, 78, thedetents may become engaged as the tabs 80 are inserted into the pockets34. Alternatively, the tubular members 76, 78 may be advanced into thepassage 38 by pushing on the shaft 86 to secure the carrier assembly 14to the tubular members 76, 78. In a further alternative, the distal ends82, 84 may simply abut the carrier assembly 14.

Turning to FIG. 6C, the obturator 18 may then be inserted into thelateral port 88, through the interior of the tubular members 76, 78 andinto the lumen 20 of the sheath 12. When the obturator 18 is fullyinserted within the sheath 12, the actuator housing 180 may be receivedin the lateral port 88, and the distal portion 182 of the obturator 18may extend beyond the distal end 24 of the sheath 12. The distal tip 184preferably is substantially soft and/or flexible such that the distalportion 182 substantially atraumatically enters the vessel 90. In thisfully inserted position, cooperating detents (not shown), e.g., on theactuator housing 180 and the lateral port 88, may be engaged to securethe obturator 18 axially within the actuator assembly 16. Alternatively,the obturator 18 may be pre-attached to the actuator assembly 16, e.g.,as a single assembly, as described in co-pending application Ser. No.10/081,723, filed on the same day as the present application and titled“Apparatus and Methods for Delivering a Closure Element”. The disclosureof this application and any references cited therein are expresslyincorporated herein by reference.

As shown in FIG. 6D, the splines 186 may then be directed to theirexpanded configuration, for example, by activating a switch (not shown)on the obturator housing 180 of the obturator 18. The sheath 12 andobturator 18 may then be moved in conjunction with one another, e.g., bymanipulating the actuator assembly 16. Preferably, the sheath 12 andobturator 18 are together partially withdrawn from the vessel 90, untilthe splines 186 contact the wall 98 of the vessel 90. Thus, the splines186 may provide a tactile indication of the position of the sheath 12with respect to the wall 98 of the vessel 90. In addition, the splines186 may assist in “presenting” the wall 98 of the vessel 90, e.g., forreceiving the clip 5 (or other closure element) if the clip 5 is toengage the wall 98.

Alternatively, one or more bleed back ports (not shown) may be used toposition the sheath 12, either instead of or in addition to theobturator 18. Such methods are described in U.S. Pat. No. 6,197,042,issued Mar. 6, 2001 or in co-pending application Ser. No. 09/680,837,filed Oct. 6, 2000. The disclosures of these references and any otherscited therein are expressly incorporated herein by reference.

Turning to FIG. 6E, with the sheath 12 properly positioned, the carrierassembly 14 may be advanced along the sheath 12, i.e., into the passage92 to deliver the clip 5. For example, a distal force may be applied tothe shaft 86, thereby advancing the tubular members 76-80 distally overthe sheath 12. Because the tubular members 76, 78 are coupled to thecarrier assembly 14, the carrier assembly 14 advances along the outersurface 13 of the sheath 12 as the tubular members 76, 78 are pusheddistally.

As the carrier assembly 14 is advanced towards the distal end 24 of thesheath 12, the carrier assembly 14 may cause the skin 44 to separatefrom the outer surface 13 of the sheath 12. Preferably, the distal end48 of the carrier member 40 includes a ramped region 50 including aramped distal surface 50 b (not shown, see FIG. 2). The ramped distalsurface 50 b may slidably engage the skin 44, peeling the skin 44 fromthe outer surface 13 of the sheath 12 and directing the skin 44outwardly away from the tines 7 of the clip 5. Thus, the ramped region50 may ensure that the tines 7 of the clip 5 do not engage the skin 44and possibly entangle or tear the skin 44 in an undesired manner.

If, as shown in FIG. 1, the skin 44 includes a weakened region 72, theweakened region 72 may tear as the carrier assembly 14 is advanced andthe skin 44 is forced to expand due to the increased size of the rampedregion 50. Alternatively, if the skin 44 is formed from an elasticmaterial, the skin 44 may simply expand and separate from the outersurface 13 to accommodate the carrier assembly 14 passing under the skin44. In a further alternative, as shown in FIGS. 3A and 3B, the skin 44may include a flap 45′ or outer portion 45″ overlying an adjacent region47′, 47″ of the skin 44. The flap 45′ or outer portion 45″ may bereleased from the adjacent region 47′, 47″ as the carrier assembly 14 isadvanced towards the distal end of the elongate member, thereby allowingthe skin 44 to separate from the outer surface 13. If the skin is bondedto the outer surface 13 of the sheath 12 by an adhesive, the adhesivemay allow the skin 44 to be peeled away from the outer surface 13 as thecarrier assembly 14 is advanced towards the distal end 24 of the sheath12.

Because the carrier assembly 14 passes beneath the skin 44, i.e.,between the skin 44 and the outer surface 13 of the sheath 12, as itadvances along the sheath 12, the skin 44 may facilitate advancing thecarrier assembly 14 through one or more intervening layers of fascia 97or other tissue. Thus, the distal end 48 of the carrier member 40 maynot directly contact the layers of fascia 97, thereby minimizing therisk of the carrier assembly 14 and/or the clip 5 catching or otherwisebeing held up by the intervening layers of fascia 97.

In addition, the tapered configuration of the ramped region 50 mayfacilitate advancing the carrier assembly through the passage 92substantially atraumatically. Further, because the clip 5 issubstantially covered by the skin 44, the tissue surrounding the passage92 may not be exposed to the tines 7 on the clip 5, which otherwise mayinadvertently catch the tissue and damage the tissue and/or the clip 5.

As shown in FIG. 6F, when the carrier assembly 14 reaches a distalposition, the clip 5 may become at least partially exposed beyond thedistal end 68 of the skin 44. In addition, the inner tubular member 76may become locked from further distal movement, consequently preventingfurther distal movement of the carrier member 40 of the carrier assembly14. Thus, subsequent distal force on the shaft 86 may cause the pushermember 42 to advance distally relative to the carrier member40, therebydeploying the clip 5 from the carrier member 40. In a preferredembodiment, the ramped region 50 includes a ramped proximal surface 50 athat may deflect the tines 7 and/or the entire clip 5 radiallyoutwardly. Thus, the ramped region 50 may direct the tines 7 outwardlyinto surrounding tissue and/or may advance the clip 5 over the rampedregion 50 and into tissue beyond the distal end 24 of the sheath 12.

In an alternative embodiment, the skin 44 may cover the clip 5 in thedistal position. As the pusher member 42 is advanced distally, the clip5 may be directed over the ramped region 50, thereby causing the tine 7to tear through the skin 44 and into surrounding tissue.

To lock the carrier member 40 in the distal position, the inner tubularmember 76 may include detents (not shown) that engage with a region ofthe hub 30 and/or sheath 12 to prevent further distal movement.Alternatively, a tether (also not shown) may be coupled to the carriermember 76 that may prevent further distal movement of the carrier member76 beyond the distal position.

Returning to FIG. 6F, the splines 186 on the obturator 18 may becollapsed before, during, or after deploying the clip 5 from the carrierassembly 14. Preferably, the splines 186 automatically return to theircollapsed configuration before the clip 5 is ejected completely from offof the carrier member 40. For example, a trigger (not shown) in theactuator assembly 16 may release a locking mechanism (also not shown) inthe actuator housing 180, whereupon the actuator housing 180 may bebiased to collapse the splines 186. In addition, the obturator 18 mayinclude a spring or other biasing mechanism to automatically withdrawthe distal portion 182 into the sheath 12 once the splines 186 arecollapsed. This feature may avoid any risk of contact between the clip 5and the splines 186, e.g., which otherwise may risk driving the tines 7of the clip 5 through the wall 98 of the vessel 90 and into the splines186. Alternatively, the tines 7 on the clip 5 may be aligned to extendbetween the splines 186, thereby avoiding any contact between the tines7 and the splines 186, and the splines 186 may be collapsed after theclip 5 is at least partially deployed.

The relative lengths of the tubular members 76, 78 and the sheath 12 maybe selected such that the distal position is at a region proximal to thewall 98 of the vessel 90. For example, it may be desirable to deploy theclip 5 within intervening tissue between the patient's skin and the wall98 of the vessel 90. Alternatively, the clip 5 may be deployed such thatthe tines 7 are driven into or through the wall 98 of the vessel 90, asshown in FIGS. 6F and 6G.

Once the clip 5 is successfully delivered, the apparatus 10 may bewithdrawn from the passage 92, leaving the clip 5 to close the openingin the wall 98 or otherwise seal the passage 92, as shown in FIG. 6G. Ifthe splines 64 of the locator member 14 are not automatically collapsedwhile advancing the housing 24, the splines 64 may be affirmativelycollapsed, e.g., by depressing a switch (not shown) on the actuatorhousing 180, either before or after deployment of the clip 5. The entireapparatus 10 may then be removed in one step, or alternatively, theobturator 18 may first be withdrawn from the sheath 12 beforewithdrawing the sheath 12, thereby leaving the clip 5 in place to closeand/or seal the passage 92. In an alternative embodiment, the distal tip184 of the obturator 18 may be formed from a bioabsorbable and/orexpandable material, e.g., collagen, and may be detachable such that thedistal tip 184 may be released within the passage 92 to enhance sealing.

Turning to FIGS. 7-9, another embodiment of an apparatus 210 is shownfor delivering a closure element, such as a clip 205, into an openingthrough tissue (not shown) for closing and/or sealing the opening.Generally, the apparatus 210 includes an introducer sheath 212, aplunger or actuator assembly 216 that may be coupled to the sheath 212and/or clip 205, and a skin 244 overlying an outer surface 213 of thesheath 212 and/or the clip 205. Optionally, the apparatus 210 may alsoinclude a locator member or obturator 218 (not shown, see FIG. 10) thatmay be insertable through the actuator assembly 216 and/or sheath 212for assisting positioning of the apparatus, similar to the embodimentdescribed above.

The sheath 212 is generally a substantially flexible or semi-rigidtubular member including a lumen 220 extending along a longitudinal axis228 between its proximal and distal ends 222, 224. The distal end 224has a size and shape to facilitate insertion into an opening throughtissue (not shown), e.g., having a tapered tip 226 for facilitatingsubstantially atraumatic introduction through a passage and/or at leastpartially into a blood vessel or other body lumen accessed via thepassage. The lumen 220 has a size for accommodating inserting one ormore devices therethrough, such as the obturator 218, a catheter, aguidewire, and the like (not shown). The sheath 212 may also include aseal (not shown) that may provide a fluid-tight seal, yet accommodateinserting one or more devices into the lumen 20, similar to theembodiment described above.

An annular hub 230 is provided on the proximal end 222 of the sheath212, e.g., attached by one or more radial spokes 231. Preferably, thehub 230 and the sheath 212 define an annular or “C” shaped passage 238between the outer surface 213 of the sheath 212 and an inner surface 237of the hub 230 that extends substantially parallel to the longitudinalaxis 228. The actuator assembly 216 may be slidably coupled to the hub230, e.g., by inserting the distal end of the actuator assembly 216 intothe passage 238. Alternatively, the hub 230 may include one or moreconnectors (not shown) on its proximal end 232 for cooperating withmating connectors (also not shown) on a housing (also not shown) of theactuator assembly 216, similar to the embodiment described above.Optionally, the hub 230 may include a side port (not shown) thatcommunicates with the lumen 220, for example, to allow infusion offluids into the lumen 220 through the sheath 212 and/or to provide a“bleed back” indicator, as described above.

The hub 230 includes a plurality of spacers or alignment tabs 234extending from a distal end 233 of the hub 230. Preferably, the tabs 234are spaced apart from the outer surface 213 of the sheath 212 and extendsubstantially parallel to the longitudinal axis 228. For example, asbest seen in FIGS. 9A-9C, an inner surface 234 a of the tabs 234 may bealigned with the inner surface 237 of the hub 230 such that the tabs 234do not obstruct the passage 238. In a preferred embodiment, the tabs 234are spaced evenly about the circumference of the hub 230, e.g., in adesired orientation relative to the passage 238, as explained furtherbelow. Alternatively, an annular ridge (not shown) may be provided thatextends continuously around the circumference of the hub 230, therebydefining a single, continuous spacer.

The clip 205, best seen in FIG. 8, is an annular-shaped member includingproximal and distal ends 206, 208 and a plurality of tissue engagingelements 207 extending from the distal end 208. In a preferredembodiment, the clip 205 includes a plurality of alternating diagonalelements 209 extending between the proximal and distal ends 206, 208.The proximal and distal ends 206, 208 of the clip 205 include curvedelements connecting adjacent diagonal elements 209, the curved elementsalternating between the proximal and distal ends 206, 208 around thecircumference of the clip 205 such that the clip 205 defines asubstantially continuous serpentine or zigzag pattern about thecircumference. Alternatively, the clip may include one or more loops(not shown) between adjacent tissue engaging elements, which may enhancea flexibility of the clip 205. Additional information on such a clip maybe found in co-pending application Ser. No. 10/081,726, filed on thesame day as the present application, and titled “Closure Apparatus andMethods for Making and Using Them”. The disclosure of this applicationand any references cited therein are expressly incorporated herein byreference.

Preferably, the tissue engaging elements are tines 207 extendingdistally from the distal end 208. Optionally, the tines 207 or thedistal end 208 may include offset elements 204, e.g., on an innersurface thereof for maintaining the tines 207 away from the outersurface 213 of the sheath, as best seen in FIGS. 9A-9C. The offsetelements 204 may simply be rounded tabs formed on an inner surface ofthe clip 205, e.g., having a thickness greater than the rest of the clip205 or may be separate elements attached to the clip 205.

In a preferred embodiment, the tines 207 are biased towards one another,e.g., for engaging tissue surrounding an opening and drawing the tissueinwardly to substantially close and/or seal the opening. For example,the distal curved elements 208 of the clip 205 may be biased to moveinwardly and/or the proximal curved elements 206 may be biased to moveoutwardly. Thus, in a preferred embodiment, the clip 205 is biasedtowards a planar configuration with the tines 207 directed inwardlytowards one another (not shown). Additional information on clipsappropriate for use with the apparatus 210 may be found in applicationSer. Nos. 09/546,998 and 09/610,238, incorporated by reference above.

Returning to FIG. 8, the clip 205 is initially carried adjacent theproximal end 222 of the sheath 212 such that the proximal end 206 of theclip 205 overlies or engages the tabs 234 on the hub 230, therebyretaining the proximal end 206 of the clip 205 away from the outersurface 213 of the sheath 212 and in a desired orientation. The spacingof the tabs 234 on the hub 230 may correspond to the spacing of theproximal curved elements 206 of the clip 205, e.g., such that eachproximal curved element 206 is held away from the outer surface 213 ofthe sheath 212 by a respective tab 234. Preferably, the tabs 234 holdthe clip 205 in the desired orientation to ensure that the clip 205 isproperly coupled to the actuator assembly 216, as described furtherbelow. In this initial position, the distal end 208 of the clip 205 mayrest against the outer surface 213 of the sheath 212, although the tines207 may be retained away from the outer surface 213 by the offsetelements 204.

The skin 244 may overlie at least a portion of the outer surface 213 ofthe sheath 212 and the clip 205. Preferably, the skin 44 extends fromthe clip 205 towards the distal end 24 of the sheath 12, e.g., having aproximal end 266 that at least partially covers the clip 205 and adistal end 268 proximate the distal end 224 of the sheath 212. The skin244 may be substantially secured over the sheath 212, therebysubstantially securing the skin 244 from moving axially relative to thesheath 212, e.g., by friction and/or by an adhesive, similar to theembodiments described above. In a further alternative, the skin 244 maybe eliminated from any of the embodiments described herein.

The skin 244 may be separable from the outer surface 213 of the sheath212 as the clip 205 is advanced from its proximal position towards thedistal end 224 of the sheath 212. The skin 244 may be formed fromsubstantially inelastic materials, e.g., such that the skin 244 may tearwhen expanded, or alternatively from elastic materials, similar to theembodiments described above. Optionally, the skin 244 may include aweakened region (not shown) extending between the proximal and distalends 266, 268 of the skin 244, and/or may include fibers (not shown)embedded in the skin 244 may bias the skin 244 to tear preferentially ina desired manner, as explained above.

The actuator assembly 216 generally includes a substantially rigidtubular member 276 including proximal and distal ends 281, 282. In apreferred embodiment, the tubular member 276 includes a slot 284 (notshown, see FIG. 7) extending at least partially between the proximal anddistal ends 281, 282. The tubular member 276 has a “C” shapedcross-section defining a diameter corresponding generally to the outersurface 213 of the sheath 212 and has a thickness such that the distalend 282 may be slidably inserted into the passage 238 between the hub230 and the sheath 212, as explained further below. The slot 284 mayhave a width corresponding to the spoke 231, thereby allowing thetubular member 276 to be directed distally through the passage 238without substantial interference by the spoke 231. Alternatively, theactuator assembly 216 may include a plurality of substantially rigidbands separated by slots (not shown) that generally define a tubularstructure or otherwise conform generally to the shape of the outersurface 213 of the sheath 212.

Optionally, the actuator assembly 216 may include a housing (not shown)that may be connected to the hub 230 and/or directly to the proximal end220 of the sheath 212. The housing may secure the actuator assembly 216to the sheath 212, may limit movement of the tubular member 276, and/ormay contain internal components (not shown) of the actuator assembly216, similar to the embodiment described above. In addition, a housingmay ensure that the actuator assembly 216 is coupled to the sheath 212in a desired orientation, e.g., to align the slot 284 of the tubularmember 276 with the spoke 231 securing the hub 230 to the sheath 212, asexplained further below.

The tubular member 276 includes a plurality of protrusions 288 on thedistal end 282 for coupling distal movement of the clip 205 to thetubular member 276. Preferably, the protrusions 288 are tabs that extendradially outwardly from the distal end 282 of the tubular member 276.The protrusions 288 may be spaced apart about the circumference of thetubular member 276, preferably in a predetermined relationship to thetabs 234 extending from the hub 230 of the sheath 212. Preferably, theprotrusions 288 are disposed between adjacent tabs 234 such that aprotrusion 288 may be aligned with each distal curved element 208 of theclip 205 when the proximal curved elements 206 are engaged over the tabs234. Thus, the distal curved elements 208 of the clip 205 may providefor pockets for receiving the protrusions 288 to couple the clip 205 tothe tubular member 276.

During assembly of the apparatus 210, the distal end 282 of the tubularmember 276 may be aligned with the passage 238 of the sheath 212, asshown in FIG. 7. The distal end 282 may be inserted into the passage238, as shown in FIG. 9A, until the protrusions 288 pass between thetabs 234, and, consequently, between the proximal curved elements 206 ofthe clip 205. Thus, as the tubular member 276 is advanced distally, theprotrusions 288 enter the pockets defined by the distal curved elements208 and engage the distal curved elements 208 of the clip 205, as shownin FIG. 9B. With the clip 205 coupled to the tubular member 276, furtherdistal movement of the tubular member 276 causes the clip 205 to movedistally, as shown in FIG. 9C. As this occurs, the proximal curvedelements leave the tabs 234 and travel along the outer surface 213 ofthe sheath 212.

If the apparatus 210 includes a skin 244 overlying the outer surface 213of the sheath 212, the skin 244 may be separated from the outer surface213 as the clip 205 is advanced towards the distal end 224 of the sheath212, similar to the embodiment described above. In one embodiment, theprotrusions 288 may have a height that is greater than a thickness ofthe clip 205 such that the protrusions 288 extend radially outwardlyfrom the outer surface 213 of the sheath 212 a greater distance than theclip 205. Thus, the protrusions 288 may cause the skin 244 to separatefrom the outer surface 213, thereby minimizing the risk of the tines 207of the clip 205 catching on the skin 244. Alternatively, the tines 206may be oriented to prevent them from catching on the skin 244 or theskin 244 may include an interior surface that is substantially slipperysuch that the tines 207 may slide along the skin 244.

The apparatus 210 may be used to deliver the clip 205 or other closureelement, similar to the embodiment described above. Initially, thesheath 212, without the actuator assembly 216, may be inserted orotherwise positioned within a blood vessel through a puncture or otherpassage. The sheath 212 is provided with the clip 205 in its proximalposition, e.g., with the proximal end 206 held by the tabs 234 extendingfrom the hub 230. The sheath 212 may be advanced over a guide wire orother rail (not shown) previously positioned through the passage intothe blood vessel using conventional procedures. In a preferred method,the blood vessel is a peripheral vessel, such as a femoral or carotidartery, although other body lumens may be accessed using the sheath 212,as will be appreciated by those skilled in the art.

One or more devices, such as a guide wire, catheter, and the like (notshown), may be inserted through the sheath 212 and advanced to a desiredlocation within the patient's body. For example, the devices may be usedto perform a therapeutic or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patient'svasculature. After completing the procedure, any device(s) may beremoved from the sheath 212, and the actuator assembly 216 may beinserted into the passage 238, as shown in FIGS. 9A and 9B, and asdescribed above. If the actuator assembly 216 includes a housing (notshown), the housing may be attached to the hub 230 and/or to the sheath212.

Alternatively, the clip 205 may be pre-loaded on the actuator assembly216, rather than on the sheath 212. For example, the clip 205 may bedisposed on the distal end 282 such that the protrusions 288 aredisposed between the diagonal elements 209 and/or the distal curvedelements 208. In this alternative, the spacers 234 on the hub 230 may beeliminated. Thus, the clip 205 may be advanced through the passage 238as the actuator assembly 216 is coupled to the sheath 212. In a furtheralternative, a pusher member (not shown) may be disposed around theactuator assembly 216 for deploying the clip 205 from the actuatorassembly 216.

As shown in FIG. 10, an obturator 218, similar to the obturator 18described above, may then be inserted into the lumen 220 of the sheath212, e.g., through a lateral port (not shown) communicating with theactuator assembly 216 or the hub 230. The distal tip 294 preferably issubstantially soft and/or flexible such that the distal portion 292substantially atraumatically enters the vessel. The obturator 218 mayinclude a plurality of splines 296 on the distal portion 292 that areexpandable from an axial collapsed configuration to a transverseexpanded configuration, such as that shown in FIG. 10. In a preferredembodiment, the splines 296 are formed from substantially rigidsegments, e.g., from stainless steel, connected by hinged regions suchthat the splines 296 may bend to the expanded configuration. When theobturator 218 is fully inserted into the sheath 212, the distal portion292 extends beyond the distal end 224 of the sheath 212. Cooperatingdetents (not shown), e.g., on the obturator 218 and the lateral port,may be engaged to secure the obturator 218 with respect to the sheath212.

With the obturator 218 inserted into the sheath 212, the splines 296 maybe directed to their expanded configuration, for example, by activatinga switch (not shown) on the proximal end of the obturator 218. Thesheath 212 and obturator 218 may then be moved in conjunction with oneanother and preferably are together partially withdrawn from the vessel96, until the splines 296 contact the wall 98 of the vessel 90. Thus,the splines 296 may provide a tactile indication of the position of thesheath 12 with respect to the wall 98 of the vessel 90. In addition, thesplines 296 may assist in “presenting” the wall 98 of the vessel 90,e.g., for receiving the clip 205 (or other closure element) if the clip205 is to engage the wall 98. Alternatively, one or more bleed backports (not shown) may be used to position the sheath 212, either insteadof or in addition to the obturator 18.

With the sheath 212 properly positioned, the clip 205 may be advancedalong the sheath 212, i.e., into the passage 92, as described above. Adistal force may be applied to the tubular member 276, thereby advancingthe clip 205 distally over the sheath 212. As the clip 205 is advancedtowards the distal end 224 of the sheath 212, the protrusions 288 and/orthe clip 205 may cause the skin 244 to separate from the outer surface213 of the sheath 212. Because the clip 205 passes beneath the skin 244,i.e., between the skin 244 and the outer surface 213, as it advancesalong the sheath 212, the skin 244 may facilitate advancing the clip 205through one or more intervening layers, e.g., of fascia (not shown),similar to the embodiment described above.

As shown in FIG. 10, when the clip 205 reaches the distal end 224 of thesheath 212, the clip 205 may become at least partially exposed beyondthe distal end 268 of the skin 244. Preferably, the clip 205 is entirelyexposed beyond the distal end 268 of the skin 244 and the tines 207 aredriven into or otherwise engage tissue adjacent the distal end 224 ofthe sheath 212. When the clip 205 is exposed, the clip 205 may begin tomove towards a planar configuration, as shown in FIG. 10, such theproximal curved elements 206 move away from the distal end 282 of thetubular member 276. The splines 296 on the obturator 218 may becollapsed before, during, or after deploying the clip 205, and theapparatus 210 may be withdrawn from the passage 92. The clip 205 maythen return to a substantially planar configuration, thereby closingand/or sealing the passage 92, similar to the embodiment shown in FIG.6G.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

What is claimed is:
 1. A method for delivering a closure element to sealan opening through tissue beneath a patient's skin, the closure elementbeing carried by a carrier assembly slidable on an outer surface of anelongate member, the elongate member comprising a sleeve memberoverlying at least a portion of the outer surface between the carrierassembly and a distal end of the elongate member and at least partiallyoverlying the carrier assembly, the elongate member being provided witha locator member slidably associated therewith, said locator memberhaving one or more expandable positioning elements on its distalportion, the method comprising: inserting the distal end of the elongatemember through the patient's skin and into an opening through tissue;advancing the locator member distally from the distal end of theelongate member; expanding said one or more positioning elements;withdrawing said locator member until said positioning elements contacttissue; following locating said positioning elements in contact with thetissue, advancing the carrier assembly carrying the closure elementtowards the distal end of the elongate member from a location distal thepatient's skin and distal the opening through tissue, the carrierassembly separating the sleeve member from the outer surface of theelongate member from a proximal end of the sleeve member toward a distalend of the sleeve member as the carrier assembly is advanced towards thedistal end; and deploying the closure element from the carrier assemblywithin the opening to substantially seal said opening, the closureelement including one or more tines engaging the tissue and remainingwithin the tissue.
 2. The method of claim 1, further comprising removingthe elongate member from the opening.
 3. The method of claim 1, whereinthe sleeve member comprises a weakened region extending towards thedistal end of the elongate member, the weakened region extending towardsthe distal end of the elongate member, the weakened region tearing asthe carrier assembly is advanced towards the distal end of the elongatemember.
 4. The method of claim 1, wherein the sleeve member expands to across-section that is larger than a cross-section of the elongate memberas the carrier assembly is advanced towards the distal end.
 5. Themethod of claim 1, wherein the sleeve member is bonded to the outersurface of the elongate member by an adhesive, and wherein the adhesivehas sufficient adhesive strength such that the sleeve member is peeledaway from the outer surface as the carrier assembly is advanced towardsthe distal end.
 6. The method of claim 1, wherein the sleeve membercomprises an outer surface that is substantially slippery forfacilitating advancement of the elongate member into the opening throughtissue.
 7. The method of claim 6, wherein the opening through tissueextends through one or more layers of fascia, and wherein the sleevemember facilitates advancement of the carrier assembly through the oneor more layers of fascia.
 8. The method of claim 1, wherein the openingthrough tissue communicates with a blood vessel, and wherein thedeploying step comprises substantially sealing the opening from bloodflow therethrough with the closure element.
 9. The method of claim 1,further comprising coupling the carrier assembly to a proximal end ofthe elongate member.
 10. The method of claim 1, wherein the sleevemember comprises a plurality of longitudinal slots, the slots opening asthe carrier assembly is advanced, thereby expanding the sleeve member.11. The method of claim 10, wherein the longitudinal slots are staggeredrelative to one another such that the sleeve member assumes a zigzagmesh configuration as it expands.
 12. The method of claim 1, furthercomprising contracting said positioning elements and withdrawing saidlocator member.
 13. The method of claim 1, wherein the distal end of theelongate member is inserted into the lumen of a blood vessel and whereinthe positioning elements of the locator member are expanded within thelumen of a blood vessel.
 14. The method of claim 13, wherein the step ofwithdrawing the locator member causes the positioning elements to comeinto contact with the wall of the blood vessel.
 15. A method fordelivering a closure element to seal an opening through tissue beneath apatient's skin, the closure element being carried by a carrier assemblyslidable on the outer surface of an elongate member, the elongate memberbeing at least partially located within a sleeve member having aproximal end disposed proximate the carrier assembly and a distal enddisposed proximate the distal end of the elongate member, the methodcomprising: inserting a distal end of the elongate member, having asleeve member located about the elongate member, through the patient'sskin and into an opening through tissue which opening is in blood flowcommunication with a lumen of a blood vessel; following locating one ormore positioning elements of a locator member in contact with the tissueand locating said distal end of the elongate member, advancing thecarrier assembly carrying the closure element towards the distal end ofthe elongate member from a location distal the patient's skin and distalthe opening through tissue, the advancement of the carrier assemblycausing the sleeve member to be disrupted from the proximal end of thesleeve member toward the distal end of the sleeve member to permit suchadvancement; and deploying the closure element from the carrier assemblyto substantially seal said opening, the closure element including one ormore tines engaging the tissue and remaining within the tissue.
 16. Themethod of claim 15, wherein said blood vessel is the femoral artery. 17.The method of claim 15, wherein the elongate member is provided with alocator member slidably associated therewith and said locator member isprovided with one or more expandable positioning elements on its distalportion, comprising the steps of advancing the locator member distallyfrom the distal end of the elongate member; expanding the said one ormore positioning elements; and withdrawing said locator member untilsaid positioning elements contact the wall of the blood vessel; the stepof withdrawing the locator member being performed prior to the step ofdeploying the closure element.
 18. A method for delivering a closureelement to seal an opening through tissue beneath a patient's skin theclosure element being carried by a carrier assembly slidable on theouter surface of an elongate member, the elongate member being at leastpartially located within a sleeve member having a proximal end disposedproximate the carrier assembly and a distal end disposed proximate adistal end of the elongate member, the method comprising: inserting adistal end of the sleeve member through the patient's skin and into anopening through tissue which opening is in blood flow communication witha lumen of a blood vessel; following locating one or more positioningelements of a locator member in contact with the tissue, advancing thecarrier assembly carrying the closure element towards the distal end ofthe elongate member from a location distal the patient's skin and distalthe opening through tissue, the advancement of the carrier assemblycausing the sleeve member to be expanded from the proximal end of thesleeve member toward the distal end of the sleeve member to permit suchadvancement; and deploying the closure element from the carrier assemblyto substantially seal said opening, the closure element including one ormore tines engaging the tissue and remaining within the tissue.
 19. Themethod of claim 18, wherein said blood vessel is the femoral artery. 20.The method of claim 18, wherein the elongate member is provided with alocator member slidably associated therewith and said locator member isprovided with one or more expandable positioning elements on its distalportion, comprising the steps of advancing the locator member distallyfrom the distal end of the elongate member; expanding the said one ormore positioning elements; and withdrawing said locator member untilsaid positioning elements contact the wall of the blood vessel; the stepof withdrawing the locator member being performed prior to the step ofdeploying the closure element.